GMK UNI
K-Number: K161741 · 2017-04-14
ApplicantMedacta International S.A.
Decision Date2017-04-14
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
GMK UNI is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2017-04-14 under approval number K161741. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GMK UNI?
GMK UNI is a medical device that received FDA 510(k) clearance on 2017-04-14. It is manufactured by Medacta International S.A.. The 510(k) number is K161741.
When was GMK UNI approved by the FDA?
GMK UNI received FDA 510(k) clearance on 2017-04-14, under approval number K161741.
What company makes GMK UNI?
GMK UNI is manufactured by Medacta International S.A..
What is the FDA product code for GMK UNI?
The FDA product code for GMK UNI is HSX.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.